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510(k) Data Aggregation

    K Number
    K041232
    Device Name
    GETTIG UNIVERSAL VIAL ACCESS PIN
    Manufacturer
    GETTIG PHARMACEUTICAL INSTRUMENT CO.
    Date Cleared
    2004-07-22

    (73 days)

    Product Code
    LHI
    Regulation Number
    880.5440
    Type
    Traditional
    Panel
    General Hospital
    Reference & Predicate Devices
    N/A
    Predicate For
    N/A
    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdpartyExpeditedreview
    Intended Use

    The intended use of the Gettig Universal Vial Access Pin is to pierce the diaphragm of single or multi dose vials to inject or withdraw fluids without the use of a needle. The Gettig Universal Vial Access Pin is indicated for use with standard medication vials.

    Device Description

    The Gettig Universal Vial Access Pin is a plastic "needle" used to pierce the diaphragm of single and multi dose vials for the injection or withdrawal of fluids. It consists of a single molded piece containing a luer hub for attachment to a disposable piston syringe and plastic "needle" for piercing the diaphragm. There is also a polypropylene cover for the "needle" portion.

    AI/ML Overview

    The provided document is a 510(k) summary for the Gettig Universal Vial Access Pin, a medical device. It does not describe a study involving an AI or algorithm or human readers for diagnostic purposes. Instead, it describes a non-clinical study to demonstrate substantial equivalence to predicate devices based on engineering standards.

    Therefore, many of the requested categories (e.g., AI performance, reader studies, training sets, ground truth for AI) are not applicable to this document.

    Here's a breakdown of the available information:

    Acceptance Criteria and Reported Device Performance

    The document does not explicitly state "acceptance criteria" for performance metrics in the way one might expect for a diagnostic or AI device (e.g., sensitivity, specificity, AUC). Instead, the "acceptance criteria" are implied by compliance with specific ISO standards demonstrating the safety and functionality of the physical device. The reported performance is that the device met these standards and was found substantially equivalent to predicate devices.

    Acceptance Criteria (Implied by Standards)Reported Device Performance
    Compliance with ISO 7886-1:1993 (Sterile Hypodermic Syringes for Single Use)Achieved - testing results revealed substantial equivalence to predicate devices (which presumably comply with this standard).
    Compliance with ISO 594-1:1986 (Conical Fittings With a 6% (Luer) Taper for Syringes, Needles and Certain Other Medical Equipment, Part 1 General Requirements)Achieved - testing results revealed substantial equivalence to predicate devices.
    Compliance with ISO 594-2:1991 (Conical Fitting With a 6% (Luer) Taper for Syringes, Needles, and Certain Other Medical Equipment. Part 2 Lock Fittings)Achieved - testing results revealed substantial equivalence to predicate devices.
    Compliance with ISO 8536-4:1998 (Part 4 Infusion Equipment for Medical Use Infusion Sets for Single Use, Gravity Feed)Achieved - testing results revealed substantial equivalence to predicate devices.

    Study Details (Non-Clinical / Substantial Equivalence)

    1. Sample size used for the test set and the data provenance:

      • Sample Size: Not explicitly stated as a number of "samples" in the traditional sense of a clinical trial or AI dataset. The testing was conducted on the Gettig Universal Vial Access Pin and the predicate devices according to the listed ISO standards. The standards themselves define the number of units or tests required for compliance.
      • Data Provenance: Not applicable in the sense of country of origin for patient data. This was a non-clinical engineering/physical testing study.

    2. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:

      • Not Applicable. Ground truth, in the context of diagnostic performance, is not relevant here. This study assessed the physical characteristics and performance of a medical instrument against engineering standards. The "ground truth" is adherence to the technical specifications defined by the ISO standards. The "experts" involved would be the engineers and technicians conducting the tests and interpreting the results against the standards.

    3. Adjudication method (e.g. 2+1, 3+1, none) for the test set:

      • Not Applicable. Adjudication methods like 2+1 are used in clinical studies with human readers or AI outputs. This was a non-clinical, standards-based engineering test.

    4. If a multi-reader multi-case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance:

      • Not Applicable. This is a physical medical device (vial access pin), not a diagnostic AI. No MRMC study was conducted.

    5. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:

      • Not Applicable. This is a physical medical device; there is no algorithm involved.

    6. The type of ground truth used (expert consensus, pathology, outcomes data, etc.):

      • Technical Compliance to ISO Standards: The "ground truth" for this substantial equivalence determination was the compliance of the device's physical properties and functionality with established international engineering standards (ISO 7886-1, ISO 594-1, ISO 594-2, ISO 8536-4). The predicate devices also serve as a benchmark for comparison within these standards.

    7. The sample size for the training set:

      • Not Applicable. This is a hardware device. There is no AI or algorithm with a training set.

    8. How the ground truth for the training set was established:

      • Not Applicable. There is no training set mentioned in this documentation.
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